title: Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.
abstract: BACKGROUND
  The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations.
  
  
  OBJECTIVE
  Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA).
  
  
  METHODS
  An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year.
  
  
  RESULTS
  The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %.
  
  
  CONCLUSIONS
  Following the pilot study and implementation at the UK MHRA, the RPPS has provided a systematic approach to drug safety issue prioritisation that should help to reduce the subjectivity of reliance on individual judgement.
authors.affiliation: Pharmacoepidemiology Unit, Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London, SW1W 9SZ, UK, suzie.seabroke@mhra.gsi.gov.uk.
authors.forename: Suzie
authors.initials: S
authors.lastname: Seabroke
authors.forename: Lesley
authors.initials: L
authors.lastname: Wise
authors.forename: Patrick
authors.initials: P
authors.lastname: Waller
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D006077:Government Agencies; D033161:Government Regulation; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000592:standards; D060735:Pharmacovigilance; D010865:Pilot Projects; D006113:United Kingdom
chemical_list: D004364:Pharmaceutical Preparations